1. Field of the Invention
The present invention generally relates to medical devices, methods and systems, particularly for the treatment of urinary incontinence.
Urinary incontinence arises in both men and women with varying degrees of severity, and from different causes. In men, the condition frequently occurs as a result of prostatectomies which result in mechanical damage to the sphincter. In women, the condition typically arises after pregnancy when musculoskeletal damage has occurred as a result of inelastic stretching of the structures which support the genitourinary tract. Specifically, pregnancy can result in inelastic stretching of the pelvic floor, the external sphincter, and the tissue structures which support the bladder and bladder neck region. In each of these cases, urinary leakage typically occurs when a patient""s abdominal pressure increases as a result of stress, e.g., coughing, sneezing, laughing, exercise, or the like.
Treatment of urinary incontinence can take a variety of forms. Most simply, the patient can wear absorptive devices or clothing, which is often sufficient for minor leakage events. Alternatively or additionally, patients may undertake exercises intended to strengthen the muscles in the pelvic region, or may attempt a behavior modification intended to reduce the incidence of urinary leakage.
In cases where such non-interventional approaches are inadequate or unacceptable, the patient may undergo surgery to correct the problem. A wide variety of procedures have been developed to correct urinary incontinence in women. Several of these procedures are specifically intended to support the bladder neck region. For example, sutures, straps or other artificial structures are often looped around the bladder neck and affixed to the pelvis, the endopelvic fascia, the ligaments which support the bladder, or the like. Other procedures involve surgical injections of bulking agents, inflatable balloons, or other elements to mechanically support the bladder neck.
An alternative procedure which is often performed to enhance support of the bladder is the Kelly plication. This technique involves midline plication of the fascia, particularly for repair of central defects. In this transvaginal procedure, the endopelvic fascia from either side of the urethra is approximated and attached together using silk or linen suture. A similar procedure, anterior colporrhaphy, involves exposing the pubocervical fascia and reapproximating or plicating portions of this tissue from either side of the midline with absorbable sutures. While the Kelly plication and its variations are now often used for repair of cystocele, this procedure was originally described for the treatment of incontinence.
Each of these known procedures has associated shortcomings. Surgical operations which involve midline plications or direct suturing of the tissue structures supporting the urethra or bladder neck region require great skill and care to achieve the proper level of artificial support. In other words, it is necessary to occlude or support the tissue sufficiently to inhibit urinary leakage, but not so much that intentional voiding is made difficult or impossible. Balloons and other bulking agents which have been inserted can migrate or be absorbed by the body. The presence of such inserts can also be a source of urinary tract infections.
For these reasons, it would be desirable to provide improved devices, systems and methods for treating urinary incontinence in men and women. In particular, it would be desirable to provide techniques for treating urinary incontinence which did not artificially compress or obstruct the urethra, but which enhanced the support and functioning of the patient""s natural pelvic tissue structures. It would further be desirable if these improved techniques could be performed rapidly in a minimally invasive manner and with good efficacy, despite normal variations in individual surgeon""s surgical skills and experience.
2. Description of the Background Art
The impact of surgical treatments of the urethra were described in Female Urology, 2nd Ed., by Shlomo Raz (1996). This reference also describes techniques of surgical repair for treatment of cystocele (including the Kelly plication and the Burch procedure) on pages 340-342, while various alternative known surgical interventions for treatment of incontinence are schematically illustrated on page 356. At least some of these procedures are also described in Female Pelvic Disorders, Investigation And Management by J. Thomas Benson (1992) on pages 239-240.
The following patents and published applications relate to the treatment of urinary incontinence. U.S. Pat. Nos. 5,437,603; 5,411,475; 5,376,064; 5,314,465; 5,304,123; 5,256,133; 5,234,409; 5,140,999; 5,012,822; 4,994,019; 4,832,680; 4,802,479; 4,773,393; 4,686,962; 4,453,536; 3,939,821; 3,926,175; 3,924,631; 3,575,158; 3,749,098; and WO 93/07815.
An electrosurgical probe for the controlled contraction of tissue of joints and for dermatological indicators is described in U.S. Pat. No. 5,458,596. A bipolar electrosurgical probe having electrodes formed over a restricted arc of its distal end for treatment of, e.g., the esophagus, as described in U.S. Pat. No. 4,765,331. An electrosurgical probe for retrograde sphincterotomy is described in U.S. Pat. No. 5,035,696.
The present invention provides improved devices, methods, and systems for the surgical treatment of urinary incontinence. The techniques of the present invention generally enhance the support provided by the natural tissues of the pelvic floor without directly applying compressive pressure against the urethra. The invention provides methods and probes that are particularly well suited for forming plications in the endopelvic fascia which are displaced laterally on either side of the midline. In the preferred embodiments, the plication probes impose a predetermined level of trauma to the approximated tissues so as to promote the formation of adhesions. These tough fibrous scar tissues can maintain the enhanced support provided by the reduction in effective support tissue length after reabsorption of a temporary fastener (such as a reabsorbable suture, staple, or the like). The use of a plicating probe which draws the tissue laterally inward toward the probe and affixes the plication not only speeds up the procedure, but also provides a fold having a fold depth within a predetermined size range so as to effectively inhibit incontinence.
In a first aspect, the present invention provides a therapy for incontinence. The therapy comprises engaging an endopelvic support tissue with a probe, and manipulating the engaged tissue with the probe to form a fold having a first portion of the tissue adjacent to a second portion of the tissue along a fold depth, the fold depth being within a predetermined range. The first and second tissue portions are then affixed together with the probe to decrease a dimension of the tissue such that incontinence is inhibited.
Generally, the tissue portions will comprise the endopelvic fascia. This tissue will ideally be drawn laterally inward to fold either towards or away from the probe, the tissue often being affixed into two separate folds disposed on opposite sides of (and separated from) the urethra. The approximated portions of the endopelvic fascia may be affixed together by advancing a fastener from the probe at least partially through each tissue portion. Suitable fasteners include suture, staples, barbed tacks, helical coils, and the like, and will preferably be at least partially bio-absorbable. Where bio-absorbable fasteners are used, the probe will preferably also promote adhesion formation between the first and second tissue portions by abrading the adjacent tissue surfaces, by transmitting an electrical current through the tissues, or the like. The probe will often draw the tissue portions towards each other so as to define a tissue fold having a tissue depth of between about 2.0 mm and 2.0 cm from the tissue surface.
In another aspect, the present invention provides a therapy for incontinence of a patient. The patient has endopelvic fascia extending laterally on first and second sides of the urethra. The therapy comprises affixing a first surface region of the endopelvic fascia on the first side of the urethra to a second surface region of the endopelvic fascia which is also on the first side of the urethra. These regions are affixed with a first fastener to as to decrease an effective length of the first side. The shortened effective lengths of the endopelvic fascia enhances the support of the urethra such that incontinence is inhibited.
Optionally, an asymmetric modification of the endopelvic fascia may effectively inhibit incontinence without treating the second side. The urethra may be laterally deflected, or the treatment may simply compensate for an asymmetric stretching of the tissue. More commonly, a third surface region of the endopelvic fascia on the second side of the urethra is affixed to a fourth surface region of the endopelvic fascia on the second side of the urethra with a second fastener so as to decrease an effective length of the second side.
In another aspect, the present invention provides an endopelvic fascia plication tool. The tool comprises a probe having a proximal end and a distal end. Means are disposed near the distal end for grasping a region of the endopelvic fascia. An actuation mechanism is coupled to the grasping means. Actuation of this mechanism draws the grasped region inward from an initial configuration having an initial area to a smaller configuration having a smaller area.
As used herein, the phrases xe2x80x9cdrawing the tissue inwardxe2x80x9d (and the like) encompasses the formation of tissue folds extending towards and/or away from the probe. The plication tool will also often include means for affixing the inward drawn region in the small configuration. The affixing means will typically comprise an electrode, adhesive, suture, staple, helical coil, barbed tack, or the like. In many of these embodiments, the affixing means will be reabsorbable, and the plication tool will further comprise means for promoting adhesion formation during the healing process. This adhesion promoting means will generally be oriented for engaging a surface of the endopelvic fascia disposed within a fold of the endopelvic fascia, the fold being formed as the grasped region is drawn inward from the initial configuration to the smaller configuration.
In yet another aspect, the present invention provides an endopelvic fascia plication system. The system comprises a probe having a proximal end and a distal end. A grasper is disposed adjacent the distal end for engaging a surface region of the endopelvic fascia. A first actuation mechanism is coupled to the grasper so that actuation of the first mechanism draws the engaged tissue inward from an initial configuration to a smaller areal configuration.
In yet another aspect, the present invention provides a therapy for incontinence. The therapy comprises decreasing a first effective length of an endopelvic fascia between a urethra and a first arcus tendinous fascia pelvis. A second effective length of the endopelvic fascia between the urethra and a second arcus tendinous fascia pelvis is also decreased. The first and second lengths are separated from the urethra so as to avoid directly compressing the urethra, thereby inhibiting incontinence without obstructing voluntary voiding.
In yet another aspect, the invention provides an incontinence therapy kit. The kit comprises a probe having a tissue folding mechanism. Instructions for using the probe are also provided. The instructions describe a method which includes the steps of forming a laterally offset fold in the endopelvic fascia and affixing the fold so as to inhibit incontinence.